BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2161835 · Received July 8, 2011

    Report

    Report Number
    1119421-2011-00843
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS, THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGY REGISTRAR REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE TIP OF THE INSERTER SUDDENLY SHOT FORWARD, PUSHING THE LENS ACROSS TO THE OTHER SIDE OF THE BAG, RUPTURING THE BAG AND CAUSING BLEEDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD. / HUNTINGTON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other